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NCT02028455 · OUTCOME

Number of Participants Who Experienced an Adverse Event Meeting the Dose-Limiting Toxicity Definition

A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia · Source last updated 2026-08-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Initial CAR T cell infusion through 30 days post infusion

What was measured

The safety of the T cell infusion at the maximum tolerated dose determined in Phase 1, and further characterized in Phase 2, will be described

Analysis population: Phase 1 cohorts: Toxicity-evaluable leukemia patients who received CAR T cells; Phase 2 cohort: Toxicity-evaluable leukemia patients treated with the Phase 2 dose, 1 x 10\^6 CAR T cells/kg, following lymphodepletion with fludarabine and cyclophosphamide

Groups in this outcome

Phase 1 - Cohort 1A

This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg

Phase 1-Cohort 1B

This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg

Phase 1-Cohort 1C

This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg

Phase 1-Cohort 1D

This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg

Phase 1-Cohort 1F1

This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide

Phase 1-Cohort 1F2

This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide

Phase 2

The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1 x 10\^6 CAR T cells/kg following lymphodepletion if indicated

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1 - Cohort 1A7
Phase 1-Cohort 1B12
Phase 1-Cohort 1C7
Phase 1-Cohort 1D5
Phase 1-Cohort 1F16
Phase 1-Cohort 1F26
Phase 281

Reported measurements

Source class 1

Number of participants who experienced an AE meeting the Dose-Limiting Toxicity definition

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 - Cohort 1A1Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1B1Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1C2Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1D2Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1F10Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1F21Not reportedNot reportedNot reportedNot reported
Phase 217Not reportedNot reportedNot reportedNot reported

Number of participants who did not experience an AE meeting the Dose-Limiting Toxicity definition

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 - Cohort 1A6Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1B11Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1C5Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1D3Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1F16Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1F25Not reportedNot reportedNot reportedNot reported
Phase 264Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        17
      title
      Number of participants who experienced an AE meeting the Dose-Limiting Toxicity definition
    2. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        64
      title
      Number of participants who did not experience an AE meeting the Dose-Limiting Toxicity definition
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      81
    units
    Participants
description
The safety of the T cell infusion at the maximum tolerated dose determined in Phase 1, and further characterized in Phase 2, will be described
groups
  1. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
    id
    OG000
    title
    Phase 1 - Cohort 1A
  2. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
    id
    OG001
    title
    Phase 1-Cohort 1B
  3. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
    id
    OG002
    title
    Phase 1-Cohort 1C
  4. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
    id
    OG003
    title
    Phase 1-Cohort 1D
  5. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
    id
    OG004
    title
    Phase 1-Cohort 1F1
  6. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
    id
    OG005
    title
    Phase 1-Cohort 1F2
  7. description
    The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1 x 10\^6 CAR T cells/kg following lymphodepletion if indicated
    id
    OG006
    title
    Phase 2
param Type
COUNT_OF_PARTICIPANTS
population Description
Phase 1 cohorts: Toxicity-evaluable leukemia patients who received CAR T cells; Phase 2 cohort: Toxicity-evaluable leukemia patients treated with the Phase 2 dose, 1 x 10\^6 CAR T cells/kg, following lymphodepletion with fludarabine and cyclophosphamide
reporting Status
POSTED
time Frame
Initial CAR T cell infusion through 30 days post infusion
title
Number of Participants Who Experienced an Adverse Event Meeting the Dose-Limiting Toxicity Definition
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice